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Avadel Pharmaceuticals Receives FDA Acceptance for New Drug Application
May. 22, 2019 08:49AM PST
Pharmaceutical InvestingAvadel Pharmaceuticals (NASDAQ:AVDL) has announced that the US Food and Drug Administration (FDA) has granted the company new drug application for its fourth product, AV001. As quoted in the press release: It has been granted Priority Review status by the FDA resulting in a six-month review period. The FDA has assigned a Prescription Drug User …
Avadel Pharmaceuticals (NASDAQ:AVDL) has announced that the US Food and Drug Administration (FDA) has granted the company new drug application for its fourth product, AV001.
As quoted in the press release:
It has been granted Priority Review status by the FDA resulting in a six-month review period. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 15, 2019.
“If approved, AV001 will be our fourth revenue producing Hospital Product,” said Greg Divis, interim Chief Executive Officer of Avadel. “We are pleased that the FDA has granted AV001 an accelerated 6-month Priority Review. Subsequent to our NDA submission, the FDA granted an NDA approval for a parenteral product with the same Active Pharmaceutical Ingredient (API) as AV001. We will continue to monitor the marketplace as we work with FDA on our application and prepare for a successful launch of AV001.”
